By Christian Nordqvist

Women who have breast implants need to know that the risk of complications and having them removed or replaced grows with time, the FDA announced. Twenty percent of women who received breast augmentation implants will have to have them removed within 10 years of the procedure. For breast reconstruction, the figure could be as high as 1 in every 2 within ten years.

The FDA has issued a report after reviewing the latest clinical and scientific data for silicone gel-filled breast implants. The agency stresses that gel-filled breast implants are effective and safe when they are used as intended. However, it is vital that patients are told about the risks before undergoing any augmentation or reconstruction procedure.

Below are some highlighted details from the report:

    * The longer a patient has silicone gel-filled implants, the higher her risk of experiencing complications and needing to have them removed and/or replaced. 1 in every 5 patients who had a breast augmentation procedure will need to have them removed within ten years.

    * Up to 1 in every 2 women who underwent breast reconstruction will have to have them removed within ten years.

    * The most common complications and outcomes are:
      – Capsular contracture – the area around the implant hardens
      – Additional surgeries
      – Removal of the implant(s)
      – The implant ruptures
      – Wrinkling
      – Asymmetry
      – Infection
      – Pain
      – Scarring

    * Complication risks have not changed since breast implants were approved.

According to preliminary data, gel filled implants do not appear to cause complications; however, larger longer-term studies are needed to confirm that there is no risk.

Preliminary safety data in the report comes from post-approval studies carried out by Allergan and Mentor, two breast implant makers. It also includes a summary and analysis of undesirable side effects (adverse events) that the FDA has received over the years, as well as a comprehensive analysis and review of recent articles published in academic journals on the safety and effectiveness of silicone gel-filled breast implants.


[Source: Medical News Today]